NOVORAPID 100 U/ML Injectable solution

Зміст інструкції

1. NovoRapid 100 units/ml injectable solution in a vial
   1. What is NovoRapid and what is it used for
   2. What you need to know before you use NovoRapid
   3. How to use NovoRapid
   4. Possible side effects
   5. How to store NovoRapid
   6. Package Contents and Other Information
2. NovoRapid Penfill 100 units/ml injectable solution in cartridge
   1. What is NovoRapid and what is it used for
   2. What you need to know before using NovoRapid
   3. How to use NovoRapid
   4. Possible side effects
   5. How to store NovoRapid
   6. Package Contents and Other Information
3. NovoRapid FlexPen 100 units/ml injectable solution in a pre-filled pen
   1. What is NovoRapid and what is it used for
   2. What you need to know before using NovoRapid
   3. How to use NovoRapid
   4. POSSIBLE SIDE EFFECTS
   5. How to store NovoRapid
   6. Contents of the pack and other information
4. NovoRapid InnoLet 100 units/ml injectable solution in prefilled pen
   1. What is NovoRapid and what is it used for
   2. What you need to know before using NovoRapid
   3. How to use NovoRapid
   4. Possible side effects
   5. How to store NovoRapid
   6. Contents of the pack and other information
5. NovoRapid FlexTouch 100 Units/ml injectable solution in prefilled pen
   1. What is NovoRapid and what it is used for
   2. What you need to know before using NovoRapid
   3. How to use NovoRapid
   4. Possible side effects
   5. How to store NovoRapid
   6. Contents of the pack and other information
6. NovoRapid PumpCart 100 units/ml injectable solution in cartridge
   1. What is NovoRapid PumpCart and what is it used for
   2. What you need to know before using NovoRapid PumpCart
   3. How to use NovoRapid PumpCart
   4. Possible side effects
   5. How to store NovoRapid PumpCart
   6. Package contents and other information
   7. Inserting a new NovoRapid PumpCart cartridge into the microinfusor
   8. Removing an empty NovoRapid PumpCart cartridge from the microinfusor

NovoRapid 100 units/ml injectable solution in a vial

insulin aspart

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, because it could be dangerous.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What NovoRapid is and what it is used for
• 2. What you need to know before using NovoRapid
• 3. How to use NovoRapid
• 4. Possible side effects
• 5. How to store NovoRapid
• 6. Contents of the pack and other information

1. What is NovoRapid and what is it used for

NovoRapid is a modern insulin (insulin analogue) with rapid action. Modern insulins are
an improved version of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents and children
aged 1 year and over with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent complications of diabetes.
NovoRapid will start to reduce blood sugar levels 10-20 minutes after injection, its
maximum effect will be within 3 hours after injection and the effect will last for 3-5 hours. Due to
this short duration of action, NovoRapid should normally be taken in association with intermediate or prolonged-acting insulin preparations. Furthermore, NovoRapid can be used for continuous
infusion in microinfusers.

2. What you need to know before you use NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the excipients of this medicine
(see section 6 Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia, that is, a low level of sugar in the
blood (see a) Summary of serious and very common side effects in section 4 ).
► If the protective cap is loose or is missing. Each vial has a plastic, tamper-evident protective cap.
If the cap is not in perfect condition when you purchase it, return the vial to the supplier.
► If NovoRapid has not been stored correctly or has been frozen (see section 5
How to store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these conditions apply. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoRapid
► Check the label to make sure it is the correct type of insulin.
► Remove the protective cap.
► Always use a new needle for each injection to prevent contamination.
► Needles and syringes must not be shared with others.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or with the adrenal, pituitary and thyroid glands.
► If there has been an increase in physical activity or a change in your usual diet, as this
may affect your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad, travelling to countries with a different time zone may
change your insulin requirements and injection times.

Changes to the skin at the injection site
The injection site must be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject it into an area with lumps, into a thinned area or into a thickened area (see section 3, How to use NovoRapid). Tell your doctor if
you notice changes to the skin at the injection site. If you are currently injecting into one of these
affected areas, consult your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes medicines.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies have been conducted in children under 1 year.

Other medicines and NovoRapid
Tell your doctor, nurse or pharmacist if you are taking or have recently taken, or might
take any other medicines.
Some medicines affect your blood sugar level and may change your insulin needs. The most important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Your blood sugar level may be raised (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as “cortisone” used to treat inflammation)
• Thyroid hormones (used to treat thyroid disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low
blood sugar level.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin, have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoRapid
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or
decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor for advice before taking this medicine. NovoRapid can be used during
pregnancy. Your insulin needs may require adjustment during pregnancy and
after delivery. It is important to control your diabetes carefully, especially to prevent
episodes of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with NovoRapid during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

Driving and operating machinery
► Ask your doctor whether it is safe for you to drive or operate machinery:

• if you have frequent episodes of hypoglycaemia
• if you find it difficult to recognise the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be
impaired, and consequently your ability to drive or operate machinery. Be aware that you could endanger yourself or others.
NovoRapid starts to work quickly, therefore hypoglycaemia may occur
more quickly after the injection compared to soluble human insulin.

Important information about some of the excipients in NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoRapid is
essentially “sodium-free”.

3. How to use NovoRapid

Dosage and when to administer insulin
Always use insulin according to your doctor's prescription and follow their advice carefully. If you are
unsure, consult your doctor, nurse or pharmacist.
NovoRapid is generally administered immediately before meals. Eat a meal or snack within 10 minutes
of the injection to avoid a low blood sugar level. If necessary, NovoRapid can
be administered immediately after a meal. See information on How and where to inject.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or the
brand of insulin you are using, a dosage adjustment by your
doctor may be necessary.
Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and over instead of human soluble insulin
when a rapid onset of action is preferred. For example, when it is difficult to dose the
child in relation to meals.

Use in particular groups of patients
If you have kidney or liver failure, or if you are over 65 years of age, you should monitor your blood sugar
regularly and talk to your doctor about adjusting your insulin dose.

How and where to inject
NovoRapid is administered by injection under the skin (subcutaneous use) or by continuous infusion with
insulin pumps. Administration with insulin pumps requires detailed instructions from
healthcare professionals. Never inject insulin directly into a vein (intravenously) or into the muscle
(intramuscularly). If necessary, NovoRapid can be administered directly into a vein, but this
must be done exclusively by doctors or healthcare professionals.
With each injection, vary the injection site within the particular area of skin that you usually use.
This can reduce the risk of developing nodules or skin indentations (see section 4, Possible
side effects). The best areas for injection are: the abdomen, the upper
arm, or the front of the thigh. Insulin will act more quickly if injected into the abdomen.
Always check your blood glucose regularly.
NPH (Neutral Protamine Hagedorn) insulin is the only type of insulin that can be mixed with
NovoRapid, and the mixture must be injected immediately under the skin (subcutaneously).
NovoRapid must be drawn into the syringe before drawing NPH insulin.

How to inject NovoRapid
If you are using only one type of insulin

• 1. Draw an amount of air into the syringe equal to the dose of insulin you need to inject. Inject the air into the vial.
• 2. Turn the vial and syringe upside down and draw the correct dose of insulin into the syringe. Remove the needle from the vial. Then expel the air from the syringe and check that the dose is correct.

If you need to mix two types of insulin

• 1. Immediately before use, rotate the vial containing NPH insulin between your hands until the liquid appears uniformly white and milky.

• 2. Draw an amount of air into the syringe equal to the dose of NPH insulin. Inject the air into the vial containing the NPH insulin and remove the needle.
• 3. Draw an amount of air into the syringe equal to the dose of NovoRapid. Inject the air into the vial containing NovoRapid. Turn the vial and syringe upside down and draw the prescribed dose of NovoRapid. Then expel the air from the syringe and check that the dose is correct.
• 4. Insert the needle into the vial containing NPH insulin, turn the vial and syringe upside down and draw the prescribed dose. Then expel the air from the syringe and check that the dose is correct. Inject the mixed solution immediately.
• 5. Always mix NovoRapid and NPH insulin in the same sequence.

How to inject NovoRapid
► Inject the insulin subcutaneously. Use the administration technique provided by your doctor or
nurse.
► Wait at least 6 seconds before removing the needle from the subcutaneous tissue to ensure you have
injected the entire dose of insulin.
► Dispose of the needle after each injection.

Use with insulin pumps
Do not mix NovoRapid with other types of insulin in insulin pumps.
Follow your doctor's instructions regarding the use of NovoRapid in the insulin pump. Before using
NovoRapid in the insulin pump, make sure you understand the instructions for use and information on
what to do in case of illness, hyperglycemia or hypoglycemia, or pump malfunction.

• Before inserting the needle, wash your hands and the skin at the insertion point thoroughly with soap and water to prevent infection at the infusion site.
• When inserting a new reservoir, make sure there are no air bubbles in either the syringe or the tube.
• The infusion set (tube and needles) must be changed according to the instructions included with the infusion set.

To fully benefit from insulin infusion and to detect any pump malfunctions, measure your blood glucose regularly.

What to do in case of insulin pump malfunction
Always keep a backup method of insulin administration for subcutaneous injection available in case of insulin pump malfunction.

If you take more insulin than you should
If you take too much insulin, your blood sugar will become too low (hypoglycemia). See a)
Summary of serious and very common side effects in section 4.

If you forget to take your insulin
If you forget to take your insulin, your blood sugar will become too high (hyperglycemia).
See c) Effects of diabetes in section 4.

If you stop taking your insulin
Do not stop taking your insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high blood sugar level (severe
hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this medicine, ask your doctor, nurse or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

a)Summary of serious and very common side effects.
Low blood sugar (hypoglycemia)is a very common side effect. It may affect more than 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; excessive hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) up to death. You can regain consciousness more quickly with a glucagon hormone injection given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, sweets, or sugary snacks with you, to be used if necessary.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount of insulin, the timing of insulin injections, food and physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should turn you onto your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoRapid or any of its ingredients (called a systemic allergic reaction) is a very rare side effect that can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

• if the signs of allergy spread to other parts of the body
• if you suddenly feel unwell, and: you start to sweat; you start to feel sick (vomiting); you have difficulty breathing; your heartbeat is fast; you feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned, or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Vision disturbances: vision disturbances may occur at the start of insulin treatment, but are usually temporary.
Swollen joints: fluid retention can cause swelling around the ankles and other joints at the start of insulin treatment. This is a phenomenon that soon disappears. If not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): If you have diabetic retinopathy and your blood sugar improves very quickly, retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1,000 people.
Peripheral neuropathy (pain due to nerve damage): a rapid improvement in blood sugar levels can induce nerve pain. This is called peripheral neuropathy and disappears spontaneously.

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

c)Other effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, flushed skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These can be the symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it can lead to diabetic coma and eventually death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and on the
packaging, after EXP.
The expiry date refers to the last day of the month indicated.
Keep the vial in the outer packaging to protect it from light.

Before opening: store in a refrigerator at 2°C - 8°C, away from freezing agents. Do not
freeze.

During use or when carried as a spare: the product can be stored for a maximum
of 4 weeks. Store below 30°C. Do not refrigerate or freeze.
Dispose of the needle after each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What NovoRapid contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 ml of injectable solution.
• The excipients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and package contents
NovoRapid is presented as an injectable solution.
Packs of 1 and 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials. Not all pack sizes may be marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer:
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.

NovoRapid Penfill 100 units/ml injectable solution in cartridge

insulin aspart

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What NovoRapid is and what it is used for
• 2. What you need to know before you use NovoRapid
• 3. How to use NovoRapid
• 4. Possible side effects
• 5. How to store NovoRapid
• 6. Contents of the pack and other information

1. What is NovoRapid and what is it used for

NovoRapid is a modern insulin (insulin analogue) with rapid action. Modern insulins are
improved versions of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents and children
from 1 year of age with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent complications of diabetes.
NovoRapid will begin to reduce blood sugar levels 10-20 minutes after injection, its
maximum effect will be within 3 hours after injection and the effect will last for 3-5 hours. Due to
this short duration of action, NovoRapid should normally be taken in association with intermediate or prolonged-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia, that is, a low level of sugar in the
blood (see a) Summary of serious and very common side effects in section 4 ).
► If the cartridge or the device containing the cartridge is leaking, is damaged or fractured
► If NovoRapid has not been stored correctly or has been frozen (see section 5
How to store NovoRapid)
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these conditions apply. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoRapid
► Check the label to make sure it is the correct type of insulin.
► Always check the cartridge, including the rubber stopper on top of the
cartridge. Do not use it if it appears damaged or if the rubber stopper has been pushed beyond the
white band on top of the cartridge. This could lead to loss of insulin.
If you suspect the cartridge is damaged, return it to the supplier. See the pen manual for
further information.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoRapid Penfill must not be shared with others.
► NovoRapid Penfill is only suitable for subcutaneous injections with a reusable pen. Talk
to your doctor if you need to inject the insulin in another way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Talk to your doctor:
► If you have kidney, liver, adrenal or pituitary gland, or thyroid problems
► If there has been an increase in physical activity or a change in your usual diet as
this may affect your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad, travelling to countries with a different time zone may
change your insulin requirements and injection times.

Changes in the skin at the injection site
The injection site must be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject it into an area with lumps, into a thinned area or into a
thickened area (see section 3, How to use NovoRapid). Tell your doctor if
you notice changes in the skin at the injection site. If you are currently injecting into one of these
affected areas, talk to your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your dose of insulin or other
diabetes medicines.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies have been
conducted in children under 1 year.

Other medicines and NovoRapid
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines affect your blood sugar level and can change your insulin needs. The most
important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart or high blood pressure conditions)
• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Your blood sugar level may be raised (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as “cortisone” used to treat inflammation)
• Thyroid hormones (used to treat thyroid disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low
blood sugar level.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or a previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or
rapid weight gain or swelling in your ankles (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoRapid
► If you drink alcohol, your insulin needs may change as your blood sugar level may
increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor for advice before taking this medicine. NovoRapid can be used during
pregnancy. Your insulin needs may require adjustment during pregnancy and
after delivery. It is important to carefully control your diabetes, especially to prevent
episodes of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with NovoRapid during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

Driving and using machines
► Ask your doctor whether it is safe for you to drive or use machines:

• if you have frequent episodes of hypoglycaemia
• if you have difficulty recognising the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be
impaired, and consequently also your ability to drive or use machines. Be aware that you could
put yourself and others at risk.
NovoRapid starts to work quickly, therefore hypoglycaemia may occur
more quickly after the injection compared to soluble human insulin.

Important information about some of the ingredients of NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoRapid is
essentially “sodium-free”.

3. How to use NovoRapid

Dosage and when to administer insulin
Always use insulin as prescribed by your doctor and follow their advice carefully. If you are unsure, consult your doctor, nurse or pharmacist.
NovoRapid is generally administered immediately before meals. Eat a meal or snack within 10 minutes
of the injection to avoid low blood sugar levels. If necessary, NovoRapid can
be administered immediately after a meal. See information on How and where to inject.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or the
brand of insulin you are using, a dosage adjustment by the
doctor may be necessary.
Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and over instead of soluble human insulin
when a rapid onset of action is preferred. For example, when it is difficult to dose the
child in relation to meals.

Use in specific patient groups
If you have kidney or liver failure, or if you are over 65 years of age, you should monitor your blood sugar
regularly and talk to your doctor about adjusting your insulin dose.

How and where to inject
NovoRapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into a muscle (intramuscularly). NovoRapid Penfill is suitable
only for subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject
your insulin using another method.
With each injection, vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin indentations (see section 4, Possible
side effects). The best areas for injecting are: the abdomen, the upper
arm or the front of the thigh. Insulin will work more quickly if injected into the abdomen.
Always check your blood sugar levels regularly.
► Do not refill the cartridge. Once empty, it must be discarded.
► NovoRapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems
and NovoFine or NovoTwist needles.
► If you are treated with NovoRapid Penfill and another Penfill insulin cartridge, you must use two
different delivery systems, one for each type of insulin.
► Always carry a Penfill cartridge with you as a spare in case you lose or damage it

How to inject NovoRapid
► Inject the insulin under the skin. Use the injection technique recommended by your doctor or nurse
and described in the pen’s instruction manual.
► Keep the needle under the skin for at least 6 seconds. Keep the button pressed down fully until
you have removed the needle from the skin. This will ensure that you have injected the correct dose and will limit the
possible backflow of blood into the needle or insulin reservoir.
► After each injection, remove and discard the needle. Store NovoRapid without the needle attached. Otherwise,
the liquid may leak, causing inaccurate dosing.

If you take more insulin than you should
If you take too much insulin, your blood sugar level will become too low (hypoglycemia). See a)
Summary of serious and very common side effects in section 4.

If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycemia).
See c) Effects of diabetes in section 4.

If you stop taking your insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high blood sugar level (severe
hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about using this medicine, ask your doctor, nurse or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

a)Summary of serious and very common side effects.

Low blood sugar (hypoglycemia)is a very common side effect. It may affect more than 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You exercise more than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; excessive hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not
treated, it can cause brain damage (transient or permanent) up to death. You can regain
consciousness more quickly with an injection of glucagon hormone by someone who knows
how to use it. If you are given glucagon, you will need glucose or a sugary snack
as soon as you regain consciousness. If you do not respond to glucagon treatment you will need to be taken
to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if
possible and then rest. Always carry glucose tablets, or sugary snacks, with you to use if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized
continue your insulin treatment.
► If you have low blood sugar, you may lose consciousness, if you have needed
the injection of glucagon, or if you have many episodes of low blood sugar, talk
to your doctor. It may be necessary to adjust the amount of insulin, the
times of taking insulin, food and physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the
risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should
turn you on your side and request immediate medical attention. It is advisable that you are not
given food or drink as this could cause you to choke.

Serious allergic reactionto NovoRapid or one of its ingredients (called a systemic allergic
reaction) is a very rare side effect that can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

• if the signs of allergy spread to other parts of the body
• if you suddenly feel unwell, and: you start to sweat; you start to feel sick (vomiting); you have difficulty breathing; your heartbeat is fast; you feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty
tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1
in 100 people). Lumps under the skin can also be caused by the build-up of a protein
called amyloid (cutaneous amyloidosis; the frequency with which this occurs is unknown). Insulin
may not work as well as it should if you inject into an area with lumps, an area
thinned or an area thickened. Change the injection site with each injection to prevent these
skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising,
swelling and itching) at the insulin injection site. These symptoms usually disappear within a few
weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see
your doctor immediately. See also Serious allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but this
reaction usually disappears.
Swollen joints: at the beginning of insulin treatment, fluid retention can cause swelling
around the ankles and other joints. This is a phenomenon that soon disappears. If this does not happen, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that can lead to vision loss): if blood sugar improves very quickly, diabetic retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1,000 people.
Peripheral neuropathy (pain due to nerve damage): If blood sugar improves very quickly,
it may cause pain originating in the nerve fibers. This is defined as acute painful neuropathy
which is usually transient.

Reporting of side effects
If you get any side effects, tell your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.

c)Other effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You haven’t injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• You exercise less than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling
sleepy or tired; dry, flushed skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be the symptoms of a very serious condition called diabetic ketoacidosis
(build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it could lead to diabetic coma and eventually death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cartridge label and on the
pack, after SCAD.
The expiry date refers to the last day of the month.
When not in use, always keep the cartridge in the outer packaging to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening: NovoRapid Penfill not in use must be stored in a refrigerator at 2°C - 8°C,
away from refrigerating agents. Do not freeze.

During use or carried as a spare: NovoRapid Penfill in use or carried as a spare must not
be stored in a refrigerator. It can be carried with you at room temperature (below 30°C)
for up to 4 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of unused medicines. This will help protect the environment.

6. Package Contents and Other Information

What NovoRapid contains

• The active ingredient is insulin aspart. Each ml contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 ml of injectable solution.
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dibasic, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and package contents
NovoRapid is presented as an injectable solution.
Packs of 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Manufacturer
The manufacturer can be identified by the batch number printed on the package flap and
on the label:

• If the second and third characters are S6, P5, K7, R7, VG, FG or ZF the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
• If the second and third characters are H7 or T6 the manufacturer is Novo Nordisk Production SAS, 45, Avenue D’Orléans F-28000 Chartres, France.

This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.

NovoRapid FlexPen 100 units/ml injectable solution in a pre-filled pen

insulin aspart

Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What NovoRapid is and what it is used for
• 2. What you need to know before you use NovoRapid
• 3. How to use NovoRapid
• 4. Possible side effects
• 5. How to store NovoRapid
• 6. Contents of the pack and other information

1. What is NovoRapid and what is it used for

NovoRapid is a modern insulin (insulin analogue) with rapid action. Modern insulins are
improved versions of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents and children
from 1 year of age onwards with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent complications of diabetes.
NovoRapid will start to reduce blood sugar levels 10-20 minutes after injection, its
maximum effect will be achieved between 1 and 3 hours after injection and the effect will last for 3-5 hours. Due to
this short duration of action, NovoRapid is normally taken in association with intermediate or prolonged-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the other ingredients of this medicine
(see section 6Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia, that is, a low level of sugar in the
blood (see a) Summary of serious and very common side effects in section 4) .
► If the FlexPen is leaking, is damaged or has cracks.
► If it has not been stored correctly or has been frozen (see section 5 How to
store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these apply. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoRapid
► Check the label to make sure it is the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoRapid FlexPen must not be shared with others.
► NovoRapid FlexPen is only suitable for subcutaneous injections. Talk to your doctor if you need
to inject the insulin in a different way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or with the adrenal, pituitary and thyroid glands.
► If there has been an increase in physical activity or a change in your usual diet, as
this may affect your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you are planning to travel abroad, travelling to countries with a different time zone may
change your insulin requirements and injection times.

Changes to the skin at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area or into a thickened area (see section 3, How to use NovoRapid). Tell your doctor if
you notice changes to the skin at the injection site. If you are currently injecting into one of these
affected areas, talk to your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes medicines dose.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies have been conducted in children under 1 year.

Other medicines and NovoRapid
Tell your doctor, nurse or pharmacist if you are taking or have recently taken, or might
take any other medicines.
Some medicines affect your blood sugar level and can change your insulin needs. The most important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• Other medicines for treating diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Your blood sugar level may be raised (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
• Thyroid hormones (used to treat thyroid disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low level of
blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or swelling in your ankles or feet.
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist

Drinking alcohol and using NovoRapid
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or
decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, trying to become pregnant or are planning a pregnancy, ask your
doctor for advice before taking this medicine. NovoRapid can be used during pregnancy.
Your insulin needs may require adjustment during pregnancy and after delivery. It is
important to control your diabetes carefully, especially to prevent episodes of hypoglycaemia,
also for the health of the baby.
► There are no restrictions on treatment with NovoRapid during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

Driving and using machines
► Ask your doctor whether it is safe for you to drive or use machines:

• if you have frequent episodes of hypoglycaemia
• if you find it difficult to recognise the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be
impaired, and consequently also your ability to drive or use machines. Be aware that you could put yourself or others at risk.
NovoRapid starts to work quickly, therefore hypoglycaemia could occur
more quickly after injection compared to soluble human insulin.

Important information about some of the ingredients of NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoRapid is
essentially “sodium-free”.

3. How to use NovoRapid

Dosage and when to administer insulin
Always use insulin according to your doctor's prescription and follow their advice carefully. If you are not
sure, consult your doctor, nurse or pharmacist.
NovoRapid is generally administered immediately before meals. Eat a meal or snack within 10 minutes
of the injection to avoid low blood sugar levels. If necessary, NovoRapid can
be administered immediately after a meal. See information on How and where to inject.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dosage adjustment by
your doctor may be necessary.

Use in children and adolescents
NovoRapid can be used in adolescents and children from 1 year of age instead of soluble human insulin when a rapid onset of action is preferred. For example, when it is difficult to dose
the child in relation to meals.

Use in special patient groups
If you have kidney or liver failure, or if you are over 65 years of age, you should monitor your blood sugar
regularly and talk to your doctor about adjusting your insulin dose.

How and where to inject
NovoRapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). NovoRapid FlexPen is suitable
only for subcutaneous injections. Talk to your doctor if you need to inject insulin using another method.
With each injection, always vary the injection site within the same area of skin that you usually use.
This can reduce the risk of developing nodules or skin indentations (see section
4, Possible undesirable effects). The best areas for injection are: the abdomen, the upper
arm or the front of the thigh. Insulin will work more quickly if injected
into the abdomen. Always check your blood glucose levels regularly.

How to use NovoRapid FlexPen
NovoRapid FlexPen is a disposable, colour-coded prefilled pen and contains insulin
aspart.
Read the instructions on how to use NovoRapid FlexPen in this leaflet
carefully. You must use the pen as described in the instructions for use of NovoRapid
FlexPen..
Always make sure you are using the correct pen before injecting insulin.

If you take more insulin than you should
If you take too much insulin, your blood sugar level will become too low (hypoglycemia). See a)
Summary of serious and very common undesirable effects in section 4.

If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycemia).
See c) Effects of diabetes in section 4.

If you stop taking your insulin
Do not stop treatment with insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high blood sugar level (severe
hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, nurse or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

a)Summary of serious and very common side effects
Low blood sugar (hypoglycemia)is a very common side effect. It may affect 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You exercise more than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; excessive hunger; temporary vision problems; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) up to death. You can regain consciousness more quickly with an injection of glucagon hormone by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, or a high-sugar snack, with you to use if needed.
► When the symptoms of hypoglycemia have disappeared or when blood sugar has stabilized continue insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount of insulin, the timing of insulin injections, food and physical activity.
Tell people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should turn you on your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoRapid or any of its ingredients (called a systemic allergic reaction) is a very rare side effect that can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

• if allergy signs spread to other parts of the body
• if you suddenly feel unwell, and: you start to sweat; you start to feel sick (vomiting); you have difficulty breathing; your heartbeat is fast; you feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which it occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Vision problems: vision problems may occur at the start of insulin treatment, but are usually temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints at the start of insulin treatment. This is a phenomenon that soon disappears. If not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar improves very quickly, retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): if blood sugar improves very quickly, it may cause pain originating in the nerve fibers. This is defined as acute painful neuropathy which is usually transient.

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

c)Other effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• You exercise less than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, flushed skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it can lead to diabetic coma and eventually death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the FlexPen label and on the
packaging, after EXP. The expiry date refers to the last day of the month.
Always keep the cap on the FlexPen when not in use to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening: NovoRapid FlexPen not in use must be stored in a refrigerator at 2°C -
8°C, away from freezing agents. Do not freeze.

During use or carried as a supply:you can carry NovoRapid FlexPen with you and keep it at a
temperature below 30°C or in a refrigerator (2°C - 8°C) for up to 4 weeks. If kept in a refrigerator,
store it away from freezing agents. Do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NovoRapid contains

• The active ingredient is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution.
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and contents of the pack
NovoRapid is presented as an injectable solution.
Packs of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled 3 ml pens. Not
all pack sizes may be marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novo Nordisk A/S, Novo Allé. DK-2880 Bagsvaerd, Denmark

Manufacturer:
The manufacturer can be identified by the batch number printed on the package tab and
on the label:

• If the second and third characters are S6, P5, K7, R7, VG, FG or ZF the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
• If the second and third characters are H7 or T6 the manufacturer is Novo Nordisk Production SAS, 45, Avenue D’Orléans F-28000 Chartres, France.

Now turn the leaflet over for information on how to use your FlexPen.
This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the website of the European Agency

Instructions on how to use NovoRapid injectable solution in FlexPen.
Read the following instructions carefully before using your FlexPen.If you do not follow
the instructions carefully, you may inject too much or too little insulin which can lead to a level of
blood sugar that is too high or too low.
FlexPen is a pre-filled pen for administering insulin. It is possible to select a
dose between 1 and 60 units in 1-unit increments. FlexPen is designed to be
used with NovoFine or NovoTwist disposable needles up to 8 mm in length.
As a precaution, always carry a spare device for administering
insulin in case FlexPen is lost or damaged.

Taking care of the pen
Your FlexPen must be handled with care.
If it leaks or has been knocked or is damaged, there is a risk of insulin leakage. This can
cause incorrect dosages, which can lead to a blood sugar level that is too high or too
low.
You can clean the outside of your FlexPen with a disinfectant wipe. Do not immerse, wash or lubricate
the pen to avoid damaging the mechanism.
Do not refill your FlexPen. Once empty, it must be discarded.

Preparing NovoRapid FlexPen
Check the name and coloured label of your pento make sure it contains the correct type of
insulin .This is particularly important if you are using more than one type of insulin. If you administer a
wrong type of insulin, the blood sugar level may become too high or too low.

A
Remove the pen cap.

B
Remove the protective seal from a new disposable needle.
Screw the needle on firmly and perpendicularly to your FlexPen.

C
Remove the outer needle cap and keep it for later.

D
Remove the inner needle cap and discard it.
Never try to put the inner needle cap back on the needle itself. You could injure yourself with the needle.

Always use a new needle for each injection. This reduces the risk of contamination, infection,
needle blockage, incorrect dosage and insulin leakage.
Be careful not to bend or damage the needle before use.

Checking the insulin flow
During normal use, small amounts of air may accumulate in the cartridge. To avoid
injecting air and to administer the correct dose of insulin:
E
Rotate the dose selector and select 2 units.

F
Hold the FlexPen with the needle pointing upwards and gently tap the cartridge with your finger a few times to
collect air bubbles at the top of the cartridge.

G
Holding the needle pointing upwards, push the injection button all the way down. The dose selector will
return to 0.
A drop of insulin should appear at the end of the needle. If this does not happen, change the needle and
repeat the procedure no more than 6 times.
If the drop of insulin still does not appear, the pen is defective and you should use a new one.

Always make sure a drop appears at the tip of the needle before the injection. This
ensures the flow of insulin. If no drop appears, you will not inject insulin, even if the
dose selector moves. This may indicate a blocked or damaged needle.
Always check the flow before the injection. If you do not check the flow, you may inject a
too low amount of insulin or not inject any at all. This can lead to a
blood sugar level that is too high.

Selecting the dose
Check that the dose selector is at 0.
H
Rotate the dose selector to select the number of units to be injected.
The dose can be increased or decreasedby rotating the selector in both directions until
the indicator shows the correct dose. When rotating the dose selector, be careful
not to press the injection button to avoid insulin leakage.
You cannot select a dose higher than the number of units remaining in the cartridge.

Before injecting insulin, always use the dose selector and indicator to see how many
units have been selected.
Do not count the pen clicks. If you select and inject the wrong dose, the blood sugar
level may become too high or too low. Do not use the scale, which only shows
approximately how much insulin is left in the pen.

Injection
Insert the needle into the skin. Use the injection technique shown by your doctor or nurse.
I
Administer the dose of insulin by pushing the injection button until the indicator reaches
0. Be careful to press only the injection button.
Rotating the dose selector will not inject insulin.

J
Keep the button pressed down fully and leave the needle in the skin for at least 6 seconds. This will ensure the
complete administration of the dose.
Withdraw the needle from the skin and release the pressure on the injection button.
Always make sure that the dose selector returns to 0 after the injection. If the dose selector
stops before reaching 0, the full dose has not been administered and may
cause a blood sugar level that is too high.

K
Insert the needle tip into the outer cap without touching the cap itself. When the needle is
covered, press the outer cap fully and then unscrew the needle.
Dispose of the needle carefully and put the cap back on the pen.

Always remove the needle after each injection and store your FlexPen without the needle attached. This
reduces the risk of contamination, infection, insulin leakage, needle blockage and
incorrect dosage.

Other important information
Anyone caring for you should be very careful when handling used needles to reduce
the risk of needle stick injuries and cross-infection.
Dispose of the used FlexPen with due care, making sure to remove the needle.
Never share the pen and needles with other people. This can lead to cross-infection.
Never share the pen with other people. The medicine may be dangerous to their
health.
Always keep the pen and needles out of the sight and reach of others, especially
children.

NovoRapid InnoLet 100 units/ml injectable solution in prefilled pen

insulin aspart

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor, nurse or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What NovoRapid is and what it is used for
• 2. What you need to know before you use NovoRapid
• 3. How to use NovoRapid
• 4. Possible side effects
• 5. How to store NovoRapid
• 6. Contents of the pack and other information

1. What is NovoRapid and what is it used for

NovoRapid is a modern insulin (insulin analogue) with rapid action. Modern insulins are
an improved version of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents and children
aged 1 year and over with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent complications of diabetes.
NovoRapid will start to reduce blood sugar levels 10-20 minutes after injection and its
maximum effect will be within 3 hours after injection and will last for 3-5 hours. Due to this
short duration of action, NovoRapid should normally be taken in association with intermediate or prolonged-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia, that is, a low level of sugar in the
blood (see a) Summary of serious and very common side effects in section 4 ).
► If the InnoLet is leaking, is damaged or has cracks.
► If it has not been stored correctly or has been frozen (see section 5 How to
store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these apply. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoRapid
► Check the label to make sure it is the correct type of insulin
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoRapid InnoLet must not be shared with others.
► NovoRapid InnoLet is only suitable for subcutaneous injections. Talk to your doctor if you need to
inject the insulin in a different way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or with the adrenal, pituitary and thyroid glands.
► If there has been an increase in physical activity or a change in your usual diet, as
this may affect your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you are planning to travel abroad, travelling to countries with a different time zone may
change your insulin requirements and injection times.

Skin changes at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject it into an area with lumps, into a thinned area or into a
thickened area (see section 3, How to use NovoRapid). Tell your doctor if you
notice skin changes at the injection site. If you are currently injecting into one of these
affected areas, consult your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes medicines dose.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies have been conducted in children under 1 year.

Other medicines and NovoRapid
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels and can change your insulin needs. The most important medicines that can affect insulin treatment are listed below.
Blood sugar levels may be lowered (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Blood sugar levels may be raised (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as “cortisone” used to treat inflammation)
• Thyroid hormones (used to treat thyroid disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• Growth hormone (medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (medicine that acts on ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) may increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low
blood sugar level.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoRapid
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or
decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your
doctor for advice before taking this medicine. NovoRapid can be used during pregnancy.
Your insulin needs may require adjustment during pregnancy and after delivery. It is
important to carefully control your diabetes, especially to prevent episodes of hypoglycaemia,
also for the health of the baby.
► There are no restrictions on the use of NovoRapid during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

Driving and using machines
► Ask your doctor whether it is safe for you to drive or use machines:

• if you have frequent episodes of hypoglycaemia
• if you have difficulty recognising the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be impaired, and this may also
affect your ability to drive or use machines. Be aware that you could
put yourself or others at risk.
NovoRapid starts to work quickly, therefore hypoglycaemia may occur
more quickly after injection compared to soluble human insulin.

Important information about some of the ingredients of NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, which means that NovoRapid is
essentially “sodium-free”.

3. How to use NovoRapid

Dosage and when to administer insulin
Always use insulin according to your doctor's prescription and follow their advice carefully. If you are
not sure, consult your doctor, nurse or pharmacist.
NovoRapid is generally administered immediately before meals. Eat a meal or snack within 10 minutes
of the injection to avoid low blood sugar levels. If necessary, NovoRapid can
be administered immediately after a meal. See information on How and where to inject.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dosage adjustment by the
doctor may be necessary.
Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and over instead of soluble human insulin
when a rapid onset of action is preferred. For example, when it is difficult to dose the
child in relation to meals.
No clinical studies with NovoRapid have been conducted in children under 1 year of age. Therefore, use
NovoRapid in children under this age only if your doctor has specifically told you to do so.

Use in particular groups of patients
If you have kidney or liver failure, or if you are over 65 years of age, you should monitor your blood sugar
regularly and talk to your doctor about adjusting your insulin dose.

How and where to inject
NovoRapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). NovoRapid InnoLet is suitable
only for subcutaneous injections. Talk to your doctor if you need to inject insulin using another method.
With each injection, vary the injection site within the particular area of skin you usually use
regularly. This can reduce the risk of developing nodules or skin indentations (see section
4, Possible undesirable effects). The best areas for injecting are: the abdomen, the upper
arm or the front of the thigh. Insulin will work more quickly if injected
into the abdomen. Always check your blood glucose regularly.

How to use NovoRapid InnoLet
NovoRapid InnoLet is a disposable prefilled pen containing insulin aspart.
Read the instructions on how to use NovoRapid InnoLet in this leaflet
carefully. You must use the pen as described in the instructions on how to use NovoRapid
InnoLet..
Always make sure you are using the correct pen before injecting insulin.

If you take more insulin than you should
If you take too much insulin, your blood sugar will become too low (hypoglycemia). See a)
Summary of serious and very common adverse effects in section 4.

If you forget to take your insulin
If you forget to take your insulin, your blood sugar will become too high (hyperglycemia).
See c) Effects of diabetes in section 4.

If you stop taking your insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high level of blood sugar (severe
hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any other questions about the use of this product, ask your doctor, nurse or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

a)Summary of serious and very common side effects.
Low blood sugar (hypoglycemia)is a very common side effect. It may affect 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; extreme hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) up to death. You may regain consciousness more quickly with a glucagon injection given by someone who knows how to use it. If glucagon is administered to you, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, or sugary snacks, sweets with you to use if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, you may lose consciousness, if you have needed a glucagon injection, or if you have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount of insulin, the timing of insulin injections, food and physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should turn you onto your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoRapid or one of its ingredients (called a systemic allergic reaction) is a very rare side effect that can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

• if the signs of allergy spread to other parts of the body
• if you suddenly feel unwell, and: you start to sweat; you feel sick (vomiting); you have difficulty breathing; your heartbeat is fast; you feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by a build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Vision disturbances: vision disturbances may occur at the start of insulin treatment, but are generally temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints at the start of insulin treatment. This is a phenomenon that soon disappears. If it does not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar improves very quickly, the retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1,000 people.
Peripheral neuropathy (pain due to nerve damage): a rapid improvement in blood sugar levels can cause nerve pain. This is called peripheral neuropathy and disappears spontaneously.

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

c)Other effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or a fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, flushed skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be the symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it could lead to diabetic coma and eventually death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the InnoLet label and on the
packaging, after EXP. The expiry date refers to the last day of the month.
Always keep the cap on the InnoLet when not in use to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening: NovoRapid InnoLet not in use must be stored in a refrigerator at 2°C -
8°C, away from refrigerating elements. Do not freeze.

During use or carried as a supply:NovoRapid InnoLet in use or carried as a supply must not
be stored in a refrigerator. It can be carried with you at room temperature (below 30°C)
for up to 4 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NovoRapid contains

• The active ingredient is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and contents of the pack
NovoRapid is presented as an injectable solution.
Packs of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be
marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Now turn the leaflet over for information on how to use your InnoLet.
This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.

Instructions on how to use NovoRapid injectable solution in InnoLet.
Read the following instructions carefully before using your InnoLet.If you do not follow
the instructions carefully, you may inject too much or too little insulin which can lead to a level of
blood sugar that is too high or too low.
InnoLet is a simple and compact pre-filled pen for administering insulin
from 1 to 50 units in 1-unit increments. InnoLet has been designed to be used
with NovoFine or NovoTwist needles up to 8 mm in length. As a precaution, always carry
an insulin delivery device with you in case your InnoLet is lost or
damaged.

To get started
Check the name and coloured labelof your InnoLet to make sure it contains the correct type
of insulin. This is particularly important if you use more than one type of insulin. If you administer
the wrong type of insulin, your blood sugar level may become too high or too low.
Remove the pen cap.

Attach the needle

• Always use a new needlefor each injection. This reduces the risk of contamination, infection, insulin leakage, needle blockage and incorrect dosage.
• Be careful not to bend or damage the needle before use.
• Remove the protective sealfrom a new single-use needle
• Screw the needle firmly and tightly onto the InnoLet(figure 1 A)
• Remove the large outer needle cap and the inner needle cap.It may be helpful to keep the large outer needle cap in the designated compartment.
• Never try to put the inner needle cap back on the needle itself. You could injure yourself with the needle.

Preparation for removing air before each injection
Small amounts of air may accumulate in the needle and cartridge during
use before each injection.
To avoid injecting air and to administer the correct dose of insulin:

• Select 2 unitsby turning the dose selector clockwise
• Hold the InnoLet with the needle pointing upwards and gently tapthe insulin cartridgeseveral times with your fingers (figure 1 B). This will cause air bubbles to collect at the top of the cartridge.
• With the needle pointing upwards, press the injection button all the way down.The dose selector will return to 0.
• Always make sure a drop of insulin comes out of the needle tip(figure 1 B) before injecting. This ensures insulin flow. If this does not happen, change the needle and repeat the procedure no more than 6 times.

If a drop does not appear, the device is defective and should not
be used.

• If no drop appears, you will not inject insulin, even if the dose selector moves. This may indicate a blocked or damaged needle.
• Always check your InnoLet before injecting. If you do not check InnoLet, you may inject too little insulin or not inject any at all. This can lead to a blood sugar level that is too high.

Selecting the dose

• Always make sure the injection button is fully pressed and the dose selector is positioned at zero.
• Select the number of unitsto be injected by turning the selector clockwise (figure 2). Do not use the insulin residue scale to measure the insulin dose
• You will feel a click for each single unit selected. The dose can be corrected by turning the selector in both directions. Make sure not to rotate the knob or correct the dose when the needle is inserted into the skin. This can lead to inaccurate dosages that can cause the blood sugar level to become too high or too low.
• Always use the dose scale and dose selector to see how many units you have selected before injecting insulin. Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may be too high or too low. Do not use the residue scale, it only shows approximately how much insulin is left in the pen.

It is not possible to select a dose higher than the number of units remaining in the cartridge.

Injection

• Insert the needle into the skin.Use the injection technique recommended by your doctor.
• Administer the dose of insulin by pushing the injection button all the way down(figure 3). You will feel clicks as the selector returns to 0.
• After the injection, wait at least 6 seconds before removing the needleto ensure complete administration of the dose.
• Make sure you do not block the dose selector during injectionas it must be free to return to 0 when the injection button is pressed. Always make sure the dose selector returns to 0 after injection. If the dose selector stops before reaching 0, the full dose has not been administered and may cause a blood sugar level that is too high.
• Dispose of the needle after each injection.

Removing the needle

• Put the large outer protective cap on and unscrew the needle(figure 4). Remove the needle with due care.
• Put the pen cap on your InnoLet to protect the insulin from light.

Always use a new needle for each injection. Remove and dispose of the needle after each injection and
store InnoLet without the needle attached. This reduces the risk of contamination, infection, insulin leakage, needle blockage and inaccurate dose.

Further important information
Anyone caring for you should be very careful when handling used needles to reduce
the risk of needle-stick injuries and cross-infection.
Dispose of the used InnoLet with due care, making sure to remove the needle.
Never share the pen and needles with other people. This can lead to cross-infection.
Never share the pen with other people. The medicine may be dangerous to their health.
Always keep InnoLet and needles out of the sight and reach of others, especially children.

Taking care of the pen
InnoLet is designed to work accurately and safely. It must be handled with care.
If it has been knocked, damaged or injured, there is a risk of insulin leakage. This can cause
incorrect dosages, which can lead to a blood sugar level that is too high or too low.
You can clean the outside of your InnoLet with a disinfecting wipe. Do not immerse, wash or lubricate
the pen to avoid damaging the mechanism and causing incorrect dosages, which can lead to a
blood sugar level that is too high or too low.
Do not refill InnoLet. Once empty it must be discarded

NovoRapid FlexTouch 100 Units/ml injectable solution in prefilled pen

insulin aspart

Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor, nurse or pharmacist
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, because it could be dangerous
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What NovoRapid is and what it is used for
• 2. What you need to know before you use NovoRapid
• 3. How to use NovoRapid
• 4. Possible side effects
• 5. How to store NovoRapid
• 6. Contents of the pack and other information

1. What is NovoRapid and what it is used for

NovoRapid is a modern insulin (insulin analogue) with rapid action. Modern insulins are
improved versions of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents and children
from 1 year of age and older with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent complications of diabetes.
NovoRapid will start to reduce blood sugar levels 10-20 minutes after injection, its
maximum effect will be within 3 hours after injection and the effect will last for 3-5 hours. Due to
this short duration of action, NovoRapid should normally be taken in association with intermediate or prolonged-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia, that is, a low level of sugar in the
blood (see a) Summary of serious and very common side effects in section 4) .
► If the FlexTouch is leaking, is damaged or has cracks.
► If it has not been stored correctly or has been frozen (see section 5 How to
store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these apply. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoRapid
► Check the label to make sure it is the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and FlexTouch must not be shared with others.
► NovoRapid FlexTouch is only suitable for subcutaneous injections. Talk to your doctor if you need
to inject the insulin in a different way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or problems with the adrenal glands, pituitary gland and thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as
this may affect your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you are planning to travel abroad, travelling to countries with a different time zone may
change your insulin requirements and injection times.

Changes to the skin at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, in a thinned area or in a thickened area (see section 3, How to use NovoRapid). Tell your doctor if
you notice changes to the skin at the injection site. If you are currently injecting into one of these
affected areas, ask your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin dose or other
diabetes medicines.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies have been conducted in children under 1 year.

Other medicines and NovoRapid
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines affect your blood sugar level and can change your insulin needs. The most important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Your blood sugar level may be raised (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as “cortisone” used to treat inflammation)
• Thyroid hormones (used to treat thyroid disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used for the

treatment of asthma

• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body’s metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low blood sugar level.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-term type 2 diabetes and heart problems or previous stroke who have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or swelling in your ankles (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoRapid
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or
decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor for advice before taking this medicine. NovoRapid can be used during pregnancy.
Your insulin needs may require adjustment during pregnancy and after delivery. It is
important to carefully control your diabetes, especially to prevent episodes of hypoglycaemia,
also for the health of the baby.
► There are no restrictions on treatment with NovoRapid during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

Driving and using machines
► Ask your doctor whether it is safe for you to drive or use machines:

• if you have frequent episodes of hypoglycaemia
• if you have difficulty recognising the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be impaired, and this may
affect your ability to drive or use machines. Be aware that you could put yourself or others at risk.
NovoRapid starts to work quickly, so hypoglycaemia may occur
more quickly after injection than with soluble human insulin.

Important information about some of the ingredients of NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, which means that NovoRapid is
essentially “sodium-free”.

3. How to use NovoRapid

Dose and when to administer insulin
Always use insulin according to your doctor's prescription and carefully follow their advice. If you are not
sure, consult your doctor, nurse or pharmacist.
NovoRapid is generally administered immediately before meals. Eat a meal or snack within 10 minutes
of the injection to avoid low blood sugar levels. If necessary, NovoRapid can
be administered immediately after a meal. See information on How and where to inject.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or the
brand of insulin you are using, a dosage adjustment by the
doctor may be necessary.

Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and over instead of human
soluble insulin when a rapid onset of action is preferred. For example, when it is difficult to dose the
child in relation to meals.
No clinical studies with NovoRapid have been conducted in children under 1 year of age. Therefore, use
NovoRapid in children under this age only if your doctor has specifically told you to do so.

Use in special patient groups
If you have renal or hepatic insufficiency, or if you are over 65 years of age, blood sugar levels should be monitored
regularly and discuss insulin dose adjustment with your doctor.

How and where to inject
NovoRapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). NovoRapid FlexTouch is suitable
only for subcutaneous injections. Talk to your doctor if you need to inject insulin using another method.
With each injection, vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin indentations (see section 4, Possible
side effects). The best areas for self-injection are: the abdomen, the front of the
arm or the front of the thigh. Insulin will work more quickly if injected into the abdomen.
Always check your blood glucose levels regularly.

How to use NovoRapid FlexTouch
NovoRapid FlexTouch is a disposable prefilled pen, colour-coded, containing
insulin aspart.
Read the instructions on how to use NovoRapid FlexTouch carefully in this leaflet
illustration. You must use the pen as described in the instructions on how to use NovoRapid
FlexTouch.
Always make sure you are using the correct pen before injecting insulin.

If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycemia).
See a) Summary of serious and very common side effects in section 4.

If you forget to take your insulin
If you forget to take insulin, your blood sugar level will become too high (hyperglycemia).
See c) Effects of diabetes in section 4.

If you stop taking your insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high blood sugar level (severe
hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, nurse or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

a)Summary of serious and very common side effects
Low blood sugar (hypoglycemia)is a very common side effect. It may affect 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; excessive hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) up to death. You may regain consciousness more quickly with a glucagon hormone injection given by someone who knows how to use it. If glucagon is given to you, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, or a high-sugar snack, with you to use if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, or if you have needed a glucagon injection, or if you have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount of insulin, the timing of insulin injections, your food, and your physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should turn you onto your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoRapid or one of its ingredients (called a systemic allergic reaction) is a very rare side effect that can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

• if the signs of allergy spread to other parts of the body
• if you suddenly feel unwell, and: you start to sweat; you feel sick (vomiting); you have difficulty breathing; your heartbeat is fast; you feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by a protein build-up called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known). Insulin may not work as well if you inject into an area with lumps, an area that is thinned, or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Vision problems: vision disturbances may occur at the start of insulin treatment, but are usually temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints at the start of insulin treatment. This is a phenomenon that soon disappears. If it does not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar improves very quickly, the retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1000 people.
Peripheral neuropathy (pain due to nerve damage): a rapid improvement in blood sugar levels can cause nerve pain. This is called peripheral neuropathy and disappears spontaneously.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

c)Other effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, flushed skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be the symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, this could lead to diabetic coma and eventually death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the FlexTouch label and
on the packaging, after EXP. The expiry date refers to the last day of the month.
Always keep the cap on the FlexTouch when not in use to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening:NovoRapid FlexTouch not in use must be stored in a refrigerator at 2°C -
8°C, away from freezing elements. Do not freeze.

During use or carried as a supply: you can carry NovoRapid FlexTouch with you and keep it at
a temperature below 30°C or in a refrigerator (2°C - 8°C) for up to 4 weeks. If kept in a refrigerator,
store it away from freezing elements. Do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NovoRapid contains

• The active ingredient is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution.
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and contents of the pack
NovoRapid is presented as an injectable solution.
Packs of 1 (with or without needles), 5 (without needles) or a multi-pack (without needles) of 2 x 5
(without needles) pre-filled 3 ml pens. Not all pack sizes may be marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer:
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Now turn the leaflet over for information on how to use your FlexTouch.
This leaflet was last approved in
Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Instructions on how to use NovoRapid 100 units/ml solution for injection in a pre-filled pen
(FlexTouch)
Read the following instructions carefully before using your pre-filled penIf you do not
follow the instructions carefully, you may inject too much or too little insulin which can lead to a
blood sugar level that is too high or too low.

Do not use the pen without receiving adequate instructionfrom your doctor or nurse.
Start by checking the pen to make sure it contains NovoRapid 100 units/ml, then look at
the illustrations below to learn about the different parts of the pen and the needle.

If you are blind or have severe visual impairment and are unable to read the dose counter
on the pen, do not use this pen without help.Ask for help from someone who has good
vision and is trained in the use of the FlexTouch pre-filled pen.
NovoRapid FlexTouch is a pre-filled pen contains 300 units of insulin and it is possible to
select a dose between 1 and 80 units in 1 unit increments. NovoRapid FlexTouch is
designed to be used with single-use needles NovoFine or NovoTwistwith a length of up to
8 mm.

Preparing the NovoRapid FlexTouch pen
Check the name and coloured label to make sure your NovoRapid FlexTouch contains the
correct type of insulin. This is particularly important if you use more than one type of insulin.
If you administer the wrong type of insulin, your blood sugar level may become too high
or too low.

ARemove the pen cap.

BCheck that the insulin in the pen is clear and colourless.
Look through the insulin window. If the insulin appears cloudy, do not use the pen.

CTake a new single-use needle and remove the protective seal.

DScrew the needle straight onto the pen. Make sure the needle is screwed on tightly.

ERemove the outer needle cap and keep it.
You will need it after the injection to remove the needle from the pen correctly.
Remove the inner needle cap and throw it away. If you try to put it back on, you could accidentally
puncture yourself with the needle.
A drop of insulin may appear on the tip of the needle. This is normal.

Always use a new needle for each injection.This reduces the risk of contamination,
insulin leakage, needle blockage and incorrect dosage.

Never use a bent or damaged needle.
Checking the insulin flow
Before each injection, to be sure you have administered the correct dose of insulin, always check
the insulin flow.

Tap the tip of the pen with your finger several times so that air bubbles
collect at the top.

HPress the injection button with your thumb until the dose counter returns to zero. The 0 must align with the dose indicator. A drop of insulin appears on the tip
of the needle.
If this does not happen, repeat steps Fto Hup to 6 times. If a drop of insulin does not appear
after these attempts, change the needle and repeat steps Fto Hagain.
Do not use the pen if a drop of insulin still does not appear.

Always make sure a drop appears on the tip of the needle before the injection. This ensures
the insulin flow. If this does not happen, do notinject the insulin, even if the dose counter
can move. This may indicate a blocked or damaged needle.

Always check the flow before the injection.If you do not check the flow, you may not inject
any insulin at all or you may inject too little. This can lead to a
blood sugar level that is too high.

Selecting the dose
Use the dose selector on the NovoRapid FlexTouch pen to select the dose. It is possible to
select up to 80 units per dose.
Select the dose you need. You can rotate the dose selector forwards and backwards.
Stop when the correct number of units is aligned with the dose indicator.
The dose selector makes a different sound (click) when rotated forwards, backwards or when it exceeds
the number of remaining units.

Before injecting the insulin, always use the dose counter and the dose indicator to
see how many units have been selected.
Do not count the pen clicks to select the dose. If you select and inject the wrong dose, the
blood sugar level may become too high or too low.
Do not use the insulin scale, which only shows approximately how much insulin is
remaining in your pen.

How much insulin is left?
The insulin scaleshows approximatelyhow much insulin is left in
the pen.

To see precisely how much insulin isleftin the pen, use the dose counter:
Rotate the dose selector until the dose counter stops. If it shows 80,
there are at least 80 unitsleft in the pen. If it shows less than 80, the number shown is the
number of units remaining in the pen.
Rotate the dose selector back until the dose counter shows 0.
If you need a number of insulin doses greater than those remaining in the pen, you can
split the dose into two pens.

Be very careful to calculate the correct number if you split the dose.
If you are unsure, inject the full dose using a new pen. If you split the dose incorrectly, you will inject too low or too high a dose of insulin, which can lead to a
blood sugar level that is too high or too low.

Injecting the dose
Use the correct injection technique to ensure you administer the entire dose
After the dose counter has returned to 0, leave the needle under the skin for at least6 seconds
to make sure you have injected the entire dose.

KRemove the needle from the skin.
After this, you may see a drop of insulin on the tip of the needle. This is normal and has
no effect on the dose administered.

Always dispose of the needle after each injection.This reduces the risk of contamination, infection,
insulin leakage, needle blockage and incorrect dosage. If the needle is blocked, do not
inject the insulin.

LBring the tip of the needle into the outer needle cap placed on a flat surface. Do not
touch the needle or the cap.
When the needle is covered, press the outer cap firmly and then
unscrew the needle. Dispose of the needle carefully and replace the cap after each use.
When the pen is empty, dispose of it without the needle attached as instructed by your doctor,
nurse or local health authority.

Always look at the dose counter to see how many units you are injecting.
The dose counter shows the exact number of units. Do not count the pen clicks. Keep
pressing the injection button until the dose counter returns to 0 after
the injection. If the dose counter stops before reaching 0, the full dose has not
been administered and may cause a blood sugar level that is too high.

Never try to put the inner needle cap back on. You could puncture yourself with the needle.

Always remove the needle after each injectionand always store the pen without the needle attached.
This reduces the risk of contamination, infection, insulin leakage, needle blockage and incorrect dosage.

Maintaining your pen
Treat the pen with care. Incorrect or improper use can cause incorrect dosages, which can lead
to a blood sugar level that is too high or too low.

• Do not leave the pen in the caror in other places where it could overheat or get too cold.
• Do not expose the pen to dust, dirt or liquids.
• Do not wash, immerse or lubricate the pen.If necessary, clean it with a mild detergent on a damp cloth.
• Do not drop the penor knock it against hard surfaces. If you drop it or suspect a problem, always screw on a new needle and check the insulin flow before the injection.
• Do not try to refill the pen. When it is empty, it must be disposed of.
• Do not try to repairor disassemble your pen.

Important information.

• Always carry the pen with you.
• Always carrywith you an extra pen and new needlesin case the pen or needles are lost or damaged
• Always keep the pen and needles out of sight and reach of others, especially children.
• Never sharethe pen and needles with other people. This can lead to cross-infection.
• Never sharethe pen with other people.The medicine may be dangerous to their health.
• You must be very careful when handling used needlesto reduce the risk of needle injury and cross-infection.

NovoRapid PumpCart 100 units/ml injectable solution in cartridge

insulin aspart

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor, nurse or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What NovoRapid PumpCart is and what it is used for
• 2. What you need to know before you use NovoRapid PumpCart
• 3. How to use NovoRapid PumpCart
• 4. Possible side effects
• 5. How to store NovoRapid PumpCart
• 6. Contents of the pack and other information

1. What is NovoRapid PumpCart and what is it used for

NovoRapid is a modern insulin (insulin analogue) with rapid action. Modern insulins are
an improved version of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents and children
aged 1 year and older with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent complications of diabetes.
NovoRapid PumpCart is used with an insulin pump and covers the entire daily insulin requirement:
both the insulin needed to cover the whole day (basal) and that for meals (bolus).
Before using NovoRapid PumpCart you must have received adequate instructions from your doctor or
nurse.

Basal insulin requirement (whole day):when using NovoRapid PumpCart with an
insulin pump, insulin is constantly administered to cover the basal insulin requirement.
If you change the basal insulin setting, the effects will begin to be felt within 10–20 minutes. If
you interrupt the action of the pump, the effect of the insulin will last for 3 to 5 hours. Before setting or
changing the amount of basal insulin, carefully read the pump's instruction manual
(user guide).

Insulin bolus requirement (meals):NovoRapid will start to lower blood sugar levels within 10–20 minutes of starting the bolus administration (see section 3, How

to use NovoRapid PumpCart, for more information on how to adjust the insulin bolus dose).
The maximum effect will be within 3 hours after bolus administration and will last for 3-5 hours.

2. What you need to know before using NovoRapid PumpCart

Do not use NovoRapid PumpCart
► If you are allergic to insulin aspart or any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia, that is, a low level of sugar in the
blood (see a) Summary of serious and very common side effects in section 4). .
► If the cartridge or the device containing the cartridge is leaking, damaged or has
cracks.
► If it has not been stored correctly or has been frozen (see section 5 How to
store NovoRapid PumpCart).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid PumpCart if any of these occur. Talk to your doctor, nurse or
pharmacist for advice.

Before using NovoRapid PumpCart
► Check the label to make sure it is the correct type of insulin
► Always check the cartridge, including the rubber stopper at the base of the cartridge. Do not use
it if you see any leakage or damage or if the stopper is beyond the white band at the
base of the cartridge. This could cause loss of insulin. If you suspect the cartridge
is damaged, return it to the supplier.
► The infusion set (tube and needles) and NovoRapid PumpCart must not be shared with others.
► NovoRapid PumpCart is only suitable for injecting under the skin (subcutaneous use) using an
insulin pump. Talk to your doctor if you need to inject insulin in another way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or with the adrenal, pituitary and thyroid glands.
► If there has been an increase in physical activity or a change in your usual diet, as
this may affect your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you are planning to travel abroad, travelling to countries with a different time zone may
change your insulin needs and injection times.

Changes to the skin at the injection site
The injection site must be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area or into a
thickened area (see section 3, How to use NovoRapid). Tell your doctor if you
notice changes to the skin at the injection site. If you are currently injecting into one of these
affected areas, consult your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes medicines.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies have been
conducted in children under 1 year.

Other medicines and NovoRapid PumpCart
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or may
take any other medicines.
Some medicines affect your blood sugar level and may change your insulin needs. The most
important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• Other medicines for treating diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Your blood sugar level may be raised (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as “cortisone” used to treat inflammation)
• Thyroid hormones (used to treat thyroid disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low level
of blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or
rapid weight gain or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoRapid
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or
decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your
doctor for advice before taking this medicine. NovoRapid can be used during
pregnancy. Your insulin needs may require adjustment during pregnancy and
after delivery. It is important to control your diabetes carefully, especially to prevent
episodes of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with NovoRapid during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

Driving and using machines
► Ask your doctor whether it is safe for you to drive or use machines:

• if you have frequent episodes of hypoglycaemia
• if you find it difficult to recognise the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be impaired, and
consequently also your ability to drive or use machines. Be aware that you may
put yourself and others at risk.

Important information about some of the ingredients of NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoRapid is
essentially “sodium-free”.

3. How to use NovoRapid PumpCart

Dosage and when to administer insulin
Always use the insulin and adjust the dose of basal insulin (throughout the day) and bolus (meals) according to your doctor’s instructions. If you are unsure, consult your doctor, nurse or pharmacist. The bolus insulin (meals) requirement must be adjusted based on the measured blood glucose level and the amount of food consumed. Eat or take a snack within 10 minutes of the bolus dose to avoid low blood sugar. If necessary, the bolus can be administered immediately after a meal.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or brand of insulin you are using, a dosage adjustment by the doctor himself may be necessary.
Use in children and adolescents
NovoRapid can be used in children and adolescents aged 1 year and over.

Use in special patient groups
If you have kidney or liver failure, or if you are over 65 years of age, you should monitor your blood sugar regularly and talk to your doctor about adjusting your insulin dose.

How and where to inject
NovoRapid PumpCart is only suitable for subcutaneous injection (subcutaneous use) using an insulin pump. Never inject insulin directly into a vein (intravenously) or into a muscle (intramuscularly). Talk to your doctor if you need to inject insulin using another method.
Before using NovoRapid PumpCart with the insulin pump, you must have received instructions on how to use the pump and information on any action to be taken in case of illness, blood sugar levels that are too high or too low, or pump malfunction. Always follow your doctor's instructions and advice when using NovoRapid PumpCart with the insulin pump.
Generally, the area for administering insulin is the abdomen. Alternatively, if recommended by your doctor, you can use the thigh or the upper arm. When you change the infusion set (tube and needle), make sure to vary the injection site. This can reduce the risk of developing nodules or skin depressions (see section 4, Possible undesirable effects). The infusion set must be changed according to the instructions in the guide provided inside the infusion set.

When using an insulin pump
It is advisable to measure your blood sugar level regularly to benefit most from insulin administration and ensure that the insulin pump is working correctly. If you notice any problems, contact your doctor.
► NovoRapid PumpCart must only be used with an insulin pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump pumps.
► NovoRapid PumpCart is a pre-filled cartridge ready for direct use in the insulin pump. Follow the pump's manual of instructions (user guide).
► To ensure the correct dose, NovoRapid PumpCart must never be used in an insulin pen.
► When used in an insulin pump, NovoRapid must never be mixed with other medicines, including other insulin medicines.
► Do not refill the cartridge. Once empty, it must be discarded.
► Always carry a spare NovoRapid PumpCart with you.
Read the instructions on how to use NovoRapid PumpCart in this leaflet carefully.

What to do in case of insulin pump malfunction
If the insulin pump is not working, make sure you have an alternative method for administering insulin subcutaneously (e.g. an injection pen).

If you take more insulin than you should
If you take too much insulin, your blood sugar will drop too low (hypoglycemia). See a) Summary of serious and very common undesirable effects in section 4.

If you forget to take your insulin
If you forget to take your insulin, your blood sugar will become too high (hyperglycemia). See c) Effects of diabetes in section 4.

If you stop taking your insulin
Do not stop taking insulin without talking to your doctor, who will tell you what to do. This could lead to high blood sugar (severe hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any other questions about the use of this product, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

a)Summary of serious and very common side effects
Low blood sugar (hypoglycemia)is a very common side effect. It may affect 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; excessive hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) up to death. You can regain consciousness more quickly with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice) and adjust the amount of insulin you administer or switch off the microinfusion pump. Measure your blood sugar if possible and then rest. Always carry glucose tablets, or high-sugar snacks with you to use if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have frequent episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount of insulin, the timing of insulin injections, your food and your physical activity.
Tell people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that if you were to faint, they should turn you on your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoRapid or one of its ingredients (called a systemic allergic reaction) is a very rare side effect that can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

• if allergy signs spread to other parts of the body
• if you suddenly feel unwell, and: you start sweating; you feel sick (vomiting); you have difficulty breathing; your heartbeat is fast; you feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which it occurs is unknown). Insulin may not work as well as it should if you inject it into an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Vision disturbances: Vision disturbances may occur at the beginning of insulin treatment, but are generally temporary.
Swollen joints: At the beginning of insulin treatment, fluid retention can cause swelling around the ankles and other joints. This is a phenomenon that soon disappears. If not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that can lead to vision loss): If you have diabetic retinopathy and your blood sugar improves very quickly, retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1,000 people.
Peripheral neuropathy (pain due to nerve damage): A rapid improvement in blood sugar levels can induce nerve pain. This is called peripheral neuropathy and disappears spontaneously.

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

c)Other effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, flushed skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it could lead to diabetic coma and eventually death.

5. How to store NovoRapid PumpCart

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging,
after ‘EXP’. The expiry date refers to the last day of the month.
Always keep the cartridge inside the packaging when not in use to protect it from light.
NovoRapid PumpCart must be protected from excessive heat and light during
storage and use.

Before opening: NovoRapid PumpCart not in use must be stored in a refrigerator at 2°C -
8°C, away from refrigerating elements. Do not freeze.

During use or carried as a spare:NovoRapid PumpCart in use must not be stored
in a refrigerator. NovoRapid PumpCart carried as a spare can be taken with you for up to 2
weeks below 30°C. Afterwards it can be used for 7 days below 37°C with a microinfuser
designed to be used with this cartridge, such as the Accu-Chek Insight and
YpsoPump microinfusers. Keep NovoRapid PumpCart in the packaging until use, to protect it from
damage. During use always protect the cartridge from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NovoRapid PumpCart contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 ml of injectable solution.
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid PumpCart and package contents
NovoRapid PumpCart is presented as an injectable solution.
Packs of 5 cartridges and multiple packs containing 25 (5 packs of 5) cartridges of 1.6 ml.
Not all pack sizes may be marketed.
The solution is clear and colourless.

Marketing Authorisation Holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Refer to the information in ‘Instructions on how to use the NovoRapid PumpCart
pre-filled cartridge’.
This leaflet was last revised in
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.

Instructions on how to use NovoRapid PumpCart pre-filled cartridge
NovoRapid PumpCart must only be used with a microinfuser designed to be
used with this cartridge, such as the Accu-Chek Insight and YpsoPump microinfusers. It must not
be used with other devices not designed for NovoRapid PumpCart, as this may
lead to an incorrect insulin dosage resulting in hyper or hypoglycaemia.
Read the following instructions carefullybefore using NovoRapid PumpCart.

Also read the microinfuser’s instruction manual (user guide)supplied with the
microinfuser.

• NovoRapid PumpCart is ready for immediate use with the microinfuser.
• NovoRapid PumpCart contains 1.6 ml of insulin aspart solution, equivalent to 160 units.
• This medicine should never be mixed with other insulin medicines.
• Do not refill NovoRapid PumpCart. When empty, it must be discarded.
• Always ensure you have NovoRapid PumpCart available as a spare.
• To ensure the correct dose, NovoRapid PumpCart must not be used in an insulin pen.
• NovoRapid PumpCart must be protected from excessive heat and light during storage and use.
• NovoRapid PumpCart must be kept out of the sight and reach of others, especially children.

• 1. Before inserting the NovoRapid PumpCart cartridge into the microinfuser
• Bring NovoRapid PumpCart to room temperature.
• Remove NovoRapid PumpCart from its packaging.
• Check the label to ensure it is NovoRapid PumpCart.
• Check the expiry date on the label and the outer packaging.
• Always check that NovoRapid PumpCart appears as it should (figure A). Do not use it,if you notice any damage or leakage or if the plunger is displaced, making the bottom of the plunger visible beyond the white band. This may cause insulin to leak. In figure A the bottom of the plunger is hidden behind the white band as it should be. If you suspect that NovoRapid PumpCart is damaged, return it to your supplier.
• Check that the insulin contained in NovoRapid PumpCart is clear and colourless. If the insulin appears cloudy, do not use NovoRapid PumpCart. The cartridge may contain a small amount of air in the form of small bubbles.

2. Inserting a new NovoRapid PumpCart cartridge into the microinfusor

• Follow the instructions in the microinfusor’s user manual provided with the microinfusor to insert a new NovoRapid PumpCart cartridge into the microinfusor.
• Insert a NovoRapid PumpCart into the cartridge compartment of the microinfusor. The plunger should be inserted first.
• Connect the infusion set with NovoRapid PumpCart by repositioning the adapter on the microinfusor.
• Follow the instructions in the microinfusor’s user manual to continue using the microinfusor.

3. Removing an empty NovoRapid PumpCart cartridge from the microinfusor

• Follow the instructions in the microinfusor’s instruction manual to remove an empty NovoRapid PumpCart cartridge from the microinfusor.
• Remove the empty NovoRapid PumpCart cartridge from the infusion set adapter.
• Dispose of the empty NovoRapid PumpCart cartridge and the used infusion set as indicated by your doctor or nurse.
• Follow the steps described in paragraphs 1 and 2 for preparing and inserting a new NovoRapid PumpCart cartridge into the microinfusor.